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Browsing College of Nursing and Health Sciences by Author "Ada, Louise"
Aims: Does the addition of botulinum toxin type A increase the effect of casting for improving wrist extension after stroke in people with upper limb spasticity?
Methods: Randomized trial with concealed allocation, assessor blinding and intention-to-treat analysis which was part of a larger trial included 18 adults with upper limb spasticity two years after stroke (89%) or stroke-like conditions (11%). The experimental group (n=7) received botulinum toxin type A injections to upper limb muscles for spasticity management followed by two weeks of wrist casting into maximum extension. The control group (n=11) received two weeks of casting only. Range of motion (goniometry) measured at baseline and after two weeks of casting. Results: Passive wrist extension for the experimental group improved over two weeks from 22 degrees (SD 16) to 54 degrees (SD 16), while the control group improved from 21 degrees (SD 29) to 43 degrees (SD 26). The experimental group increased passive wrist extension 13 degrees (95% CI 4 to 31) more than the control group which was not statistically significant.
Conclusion: Joint range of motion improved over a two-week period for both groups. Botulinum toxin type A injection followed-by casting produced a mean, clinically greater range of motion than casting alone, therefore, a fully-powered trial is warranted.
Botulinum toxin-A is provided for adults with post-stroke spasticity. Following injection, there is a variation in the rehabilitation therapy type and amount provided. The purpose of this study was to determine if it is feasible to add intensive therapy to botulinum toxin-A injections for adults with spasticity and whether it is likely to be beneficial.
Randomized trial with concealed allocation, assessor blinding, and intention to treat analysis. Thirty-seven adults (n = 3 incomplete or lost follow-up) with spasticity in the upper or lower limb were allocated to one of three groups: experimental group received a single dose of botulinum toxin-A plus an intensive therapy for 8 weeks, control group 1 received a single dose of botulinum toxin-A only, and control group 2 received intensive therapy only for 8 weeks. Feasibility was measured by examining recruitment, intervention (adherence, acceptability, safety), and measurement. Benefit was measured as goal achievement (Goal Attainment Scale), upper limb activity (Box and Block Test), walking (6-min walk test) and spasticity (Tardieu scale), at baseline (week 0), immediately after (week 8), and at three months (week 12).
Overall recruitment fraction for the trial was 37% (eligibility fraction 39%, enrolment fraction 95%). The 26 participants allocated to receive intensive rehabilitation attended 97% of clinic-based sessions (mean 11 ± 2 h) and an averaged 58% (mean 52 ± 32 h) of prescribed 90 h of independent practice. There were no study-related adverse events reported. Although participants in all groups increased their goal attainment, there were no between-group differences for this or other outcomes at week 8 or 12.
Providing intensive therapy following botulinum toxin-A is feasible for adults with neurological spasticity. The study methods are appropriate for a future trial. A future trial would require 134 participants to detect a between-group difference of 7 points on Goal Attainment Scale t-scores with an alpha of 0.05 and power of 80%.